MAUDE Adverse Event Report: COOK INC COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS

Model Number N/A

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

Patient Problem Pericardial Effusion (3271)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Common name: device, biopsy, endomyocardial; product code: dwz; (b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.

Event Description

It is alleged that a patient experienced a pericardial effusion after a physician used a cook flexible myocardial biopsy forceps product set for a myocardial biopsy procedure.The complainant reported that the use of the cook flexible myocardial biopsy forceps was successful and the product worked as it should.However, a puncture to the right v.Femoralis was reported in relation to an "angiokit." the pericardial effusion was successfully stopped with a tamponade, and it has not been reported that the patient experienced any further adverse events.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and inspection of unused product from same lot was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, one unused device from the same lot was returned for investigation and analysis.The device was functionally tested and the handle opened and closed the cups as designed and all measurements were within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number from the same facility and same issue.Based on the information provided, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6752306
• MDR Text Key: 81362353
• Report Number: 1820334-2017-02108
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 00827002053892
• UDI-Public: (01)00827002053892(17)220512(10)7909909
• Combination Product (y/n): N
• PMA/PMN Number: K883723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• 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: FBF-5.2-120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Weight: 81