MAUDE Adverse Event Report: COOK INC MICROPUNCTURE ACCESS SET; DYB INTRODUCER, CATHETER

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: 4-french coaxial micropuncture set.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 a 4- french coaxial micropuncture set used during a procedure in which a 12-fr drainage catheter perforated the patient's 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).

Event Description

Additional information was received.The device was placed using both ultrasound and fluoroscopy.Per the physician, the cook device did not malfunction.The elderly patient had scoliosis and kyphosis.Because the anatomy was abnormal, imaging with ultrasound guidance was reportedly confusing, and the aorta was mistaken for the pleural effusion during catheter placement.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, h6 (annex g).H6 (annex g): there has been no alleged malfunction of any component of this device.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 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.

Event Description

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

Manufacturer Narrative

Summary of event: as reported, a 4- french coaxial micropuncture set was used during a procedure in which a 12-fr drainage catheter perforated the patient's descending aorta.This was reported via 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.Per the physician, the cook device did not malfunction.The elderly patient had scoliosis and kyphosis.Because the anatomy was abnormal, imaging with ultrasound guidance was reportedly confusing, and the aorta was mistaken for the pleural effusion during catheter placement.Investigation evaluation: reviews of the device history record, instructions for use (ifu), quality control procedure, and specifications were conducted during the investigation.The complaint device was not returned to cook for investigation.As the hospital name and the date of event were not provided, cook could not complete a review of the sales history to identify the complaint lot.Cook completed a review of the device master record and concluded that sufficient controls are in place to detect damage prior to distribution.There is no indication that this device was manufactured out of specification.The instructions for use (ifu) precautions, "when inserting, manipulating or withdrawing a drive through an introducer, always maintain introducer position." based upon the available information and results of the investigation, cook has concluded that cause of the event is most likely procedural technique/user error.The reporting authors state that a micropuncture set was placed in ¿what was thought to be the small effusion¿.Once the 12fr drainage catheter was inserted into the pre-established access site, however, it was noted that the user had accessed the aorta and not the pleural effusion.It was noted that sonographic guidance was used for device placement.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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: MICROPUNCTURE ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• 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: 12500828
• MDR Text Key: 272485863
• Report Number: 1820334-2021-02183
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• 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: 02/04/2022; 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 12-FRENCH MULTIPURPOSE DRAINAGE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female