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 Problem Hemorrhage/Bleeding (1888)

Event Date 08/19/2011

Event Type  Injury  

Manufacturer Narrative

Suspect medical device: device is an unspecified 10.0 fr 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 a testicular artery injury possibly due to drainage catheter exchange was taken from the following article: niederhauser,b.Et.Al., ¿testicular artery embolization for the treatment of iatrogenic hemorrhage: report of two cases.¿ journal of vascular and interventional radiology 22.9 (2011): 1347-1348.The article contains "two cases of testicular artery embolization performed for the treatment of iatrogenic hemorrhage.[one] was of uncertain etiology¿resulting either from an endoscopic duodenal perforation or from injury during a drainage catheter exchange (case report 1)." "a (b)(6) year-old man with unresectable pancreatic adenocarcinoma presented to our department with a duodenal perforation after endoscopic ultrasound and biopsy.A resulting retroperitoneal fluid collection was controlled using a 12.0-f pigtail drainage catheter (cook, inc, bloomington, indiana) placed under computed tomography (ct) guidance from a lateral approach using a modified seldinger technique.After 4 days of continued high-output drainage, a sinogram was performed, which showed communication to the third portion of the duodenum through a sizable (1 cm) defect.The 10-f drainage catheter (multipurpose drainage catheter; cook, inc) was replaced over a stiff guide wire (lunderquist-ring torque wire, cook, inc) and repositioned for better control of the leak.Over the next 2 days, the patient had intermittent bloody output from the drainage catheter and nasogastric tube, and a ct scan showed a possible vascular pseudoaneurysm in the region of the drain with no significant retroperitoneal hematoma.Endoscopy with clipping of the duodenal perforation was performed; no endoluminal blood was noted.A mesenteric angiogram was requested 4 days after the first catheter exchange when frank blood and clot were again noted in the nasogastric tube and drainage catheter, along with a 4-day hemoglobin decline of 4.3 g/dl (12.9 g/dl to 8.6 g/dl).Injection of contrast agent in the right renal artery showed the right testicular artery arising from the upper pole branch of the right renal artery with an area of active extravasation immediately adjacent to the drainage catheter (fig, a).The testicular artery was selectively injected using a microcatheter.Embolization was performed both proximal and distal to the pseudoaneurysm using two 0.018-inch, 1.0 cm long (hilal embolization microcoil; cook, inc) and two 0.018-inch 3 x 2 mm tornado (cook, inc) coils; no further active bleeding was seen after embolization (fig, b)." no other adverse effects were reported or contained within the article.The 12 fr pigtail drain is captured in the report with patient identifier (b)(6).The 10 fr multipurpose drain is captured in the report with patient identifier (b)(6) (this report).The lunderquist-ring torque wire is captured in the report with patient identifier (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation in the literature article " testicular artery embolization for the treatment of iatrogenic hemorrhage: report of two cases¿ it was reported that injury to a testicular artery occurred possibly due to a drainage catheter exchange.This investigation pertains to the cook 10-f multipurpose drainage catheter (rpn and lot number unknown).The authors report the following: ¿a 73-year-old man with unresectable pancreatic adenocarcinoma presented to our department with a duodenal perforation after endoscopic ultrasound and biopsy.A resulting retroperitoneal fluid collection was controlled using a 12.0-f pigtail drainage catheter (cook, inc, bloomington, indiana) placed under computed tomography (ct) guidance from a lateral approach using a modified seldinger technique.After 4 days of continued high-output drainage, a sinogram was performed, which showed communication to the third portion of the duodenum through a sizable (>1 cm) defect.The 10-f drainage catheter (multipurpose drainage catheter; cook, inc) was replaced over a stiff guide wire (lunderquist ring torque wire, cook, inc) and repositioned for better control of the leak.Over the next 2 days, the patient had intermittent bloody output from the drainage catheter and nasogastric tube, and a ct scan showed a possible vascular pseudoaneurysm in the region of the drain with no significant retroperitoneal hematoma.Endoscopy with clipping of the duodenal perforation was performed; no endoluminal blood was noted.A mesenteric angiogram was requested 4 days after the first catheter exchange when frank blood and clot were again noted in the nasogastric tube and drainage catheter, along with a 4-day hemoglobin decline of 4.3 g/dl (12.9 g/dl to 8.6 g/dl).Injection of contrast agent in the right renal artery showed the right testicular artery arising from the upper pole branch of the right renal artery with an area of active extravasation immediately adjacent to the drainage catheter (fig, a).The testicular artery was selectively injected using a microcatheter.Embolization was performed both proximal and distal to the pseudoaneurysm using two 0.018-inch, 1.0 cm long (hilal embolization microcoil; cook, inc) and two 0.018-inch 3 x 2 mm tornado (cook, inc) coils; no further active bleeding was seen after embolization.¿ no other adverse events were reported for this event.Reviews of the documentation, including the instructions for use (ifu), quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify 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 in the article.Cook also reviewed product labeling.The product ifu, [t_multi_rev5] ¿multipurpose drainage catheter,¿ provides the following information to the user related to the reported failure mode: intended use ¿multipurpose drainage catheters are intended for percutaneous drainage in a variety of drainage applications (e.G., nephrostomy, biliary, and abscess), either by direct stick or seldinger access technique.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.¿ evidence provided by the dmr and product labeling, suggests there is no indication this device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned product and the results of our investigation, it was concluded that an adverse event related to the procedure lead to the event.It was reported that injury to a testicular artery occurred possibly due to a drainage catheter exchange.It is possible difficulty advancing the catheter may have led the user to use excessive force which could¿ve caused the event.This cannot be confirmed without additional information.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.

Event Description

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

• 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: 12541223
• MDR Text Key: 273632106
• Report Number: 1820334-2021-02231
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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: 09/13/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/24/2022
• 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: COOK 12 FR PIGTAIL DRAIN; COOK LUNDERQUIST-RING TORQUE WIRE; COOK 12 FR PIGTAIL DRAIN; COOK LUNDERQUIST-RING TORQUE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male