MAUDE Adverse Event Report: COOK INC MULTIPURPOSE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 01/30/2004

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: device is unspecified 12-french multipurpose drainage catheter pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The below report of inadvertent placement of a 12 fr.Cook multipurpose drainage catheter in the descending aorta was taken from the following article: hatfield, m.Et.Al., "angio-seal device used for hemostasis in the descending aorta.American journal of roentgenology 183.3 (2004): 612-614."an (b)(6) year-old woman was admitted from a nursing home with a chief complaint of shortness of breath.The family requested minimal palliative care.The portable chest radiograph (fig.1a) obtained at admission showed an atelectatic left lower lobe with a moderate left effusion, hyperinflation of the right lung, and cardiomegaly.Ct was not ordered before the procedure, and the patient had no further preprocedural workup.The patient was referred to the radiology department for placement of a percutaneous chest tube for decompression of the left effusion and reexpansion of the left lung.Sonographic guidance without color-flow doppler sonography was used.Conscious sedation was provided.With the patient in the right decubitus position, a cook 4- french coaxial micropuncture set (cook) was placed in what was thought to be the small effusion via a left posterolateral puncture.Care was taken to avoid the enlarged left ventricle.The tract was serially dilated, and a 12-french cook multipurpose drainage catheter (cook) was placed to function as a chest tube.Its tip was positioned overlying the posterior left chest cavity.A specimen was not obtained because diagnostic fluid was not requested.The chest tube was connected to [a competitor] water seal chest drain [manufacturer].Rapid filling of the collection chamber with sanguineous or serosanguineous material was noted, and the patient became tachycardic and hypotensive.The chest tube was immediately clamped, and iv fluids were administered aggressively.A hand injection of contrast material into the chest catheter showed the chest tube to be within the thoracic arch of the aorta.(fig.1b).The vital signs quickly stabilized.A total of approximately 800 ml of blood was drained.The patient¿s blood was typed and crossmatched, and she was subsequently transfused with 2 u.The thoracic surgery service, the patient¿s family, and her primary physician were consulted.After discussing various treatment options and recognizing the patient¿s poor surgical risk, we decided that the best treatment was to attempt placement of one or two 8-french angio-seal vascular closure devices at the aortic puncture site.This off-label use and other treatment options were discussed with the patient¿s family.A sheath was placed via a right common femoral arterial puncture with its tip in the descending aorta.A deflated 27-mm occlusion balloon was positioned just above the thoracic puncture site to control any future potential arterial hemorrhage and for additional angiographic injections of contrast material.The drainage catheter was removed and replaced with a 9- french 25-cm long [product name] vascular sheath [manufacturer] with its tip in the thoracic arch.A 9-french sheath was selected because its outer diameter is roughly 11 to 12 french.Two guidewires were then placed, and the sheath was removed.First, a single 8-french angio-seal vascular closure device was deployed in the standard fashion.Trace amounts of hemorrhage were noted on follow-up angiography performed by injecting contrast material through the balloon occlusion catheter (fig.1c).A second 8-french angio-seal vascular closure device was deployed.Again, minimal continued hemorrhage was observed on aortography (fig.1d).Gentle percutaneous traction on the two device strings was applied for 10 min.Follow-up angiography showed no evidence of hemorrhage (fig.1e).The sutures were then taped taut to the skin with skin closure strips [manufacturer].The following day, the sutures were cut flush with the skin.After we were confident that the hemorrhage had been controlled, a second 12-french catheter was then placed with its tip in the mid chest cavity using a lateral approach and sonographic guidance.Approximately 140 ml of clear yellow fluid was removed from the left pleural space, and no significant hemorrhage was identified.The patient recovered completely.Over the next few days, the chest tube drained a small amount of yellow fluid and no blood.Chest ct performed 5 days later showed no sign of hemorrhage (fig.1f).Unfortunately, the chest tube was unsuccessful in reexpanding the left lung, which progressively collapsed.The patient died 10 days later.The underlying cause of the atelectatic left lung was unknown." the 12-french multipurpose drainage catheter is captured in the medwatch report with patient identifier (b)(6).The 4- french coaxial micropuncture set is captured in the medwatch report with patient identifier (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6- annex g.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

In additional information, the physician reported that fluoroscopy and ultrasound imaging were used to place the device.It was also noted that due to the patient's age and abnormal anatomy, the image guidance was confusing which resulted in the user mistaking the aorta for the pleural effusion while using ultrasound.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: a 2004 journal article ¿angio-seal device used for hemostasis in the descending aorta¿ by m.K hatfield et.Al.Stated that a 12fr cook drainage catheter inadvertently punctured a patient¿s aorta during a placement for decompression of the left lung effusion and re-expansion of the left lung.Imaging was used after the procedure to confirm catheter position but was not used during placement.The aorta was repaired and the hemorrhage that occurred was resolved.However, due to the progression of the patient¿s underlying condition (atelectasis of the left lung), the patient expired 10 days later.Reviews of the documentation, including the instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are sufficient controls in place to detect this failure mode prior to distribution.A review of the device history record (dhr) could not be conducted due to the lack of lot information provided by the facility.There is no indication this device was manufactured out of specification or that there are nonconforming material in the house or in the field.Cook also reviewed product labeling.The current product ifu, [t_multi_rev5] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: warnings: ¿if catheter has become malpositioned or if drainage ceases, the catheter should be promptly exchanged or removed.Precautions: these products are intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of percutaneous drainage catheters should be employed.Manipulation of products requires ultrasound, fluoroscopy, or other imaging guidance.Catheters should be irrigated on a routine basis to ensure function.Traction on the locking suture, if present, should be sufficient to ensure adequate retention of the tup, but should not be overly tight.Verify catheter tip configuration by fluoroscopy.Instructions for use: catheter placement: under fluoroscopic control, perform standard techniques for placement of percutaneous drainage catheters, either by seldinger access or trocar access.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned product and the results of our investigation, it was concluded that an unintended user error likely caused the event.The customer stated that imaging had been used after the placement to confirm catheter position but was not used during placement.It was discovered the catheter had been placed into the thoracic arch of the aorta.The current product ifu states ¿manipulation of products requires ultrasound, fluoroscopy, or other imaging guidance.¿ there is no evidence of manufacturing deficiency.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: MULTIPURPOSE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12501126
• MDR Text Key: 272485088
• Report Number: 1820334-2021-02184
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 01/18/2022; 07/06/2022
• Supplement Dates FDA Received: 01/27/2022; 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATRIUM MEDICAL OCEAN WATER SEAL CHEST DRAIN; COOK 4-FRENCH COAXIAL MICROPUNCTURE SET
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female