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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Report source: foreign, company representative, health professional 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
• MDR Report Key: 6764953
• Report Number: 1820334-2017-02107
• Device Sequence Number: 1412214
• Product Code: DWZ
• UDI-Device Identifier: 00827002053892
• UDI-Public: (01)00827002053892(17)220512(10)7909909
• Combination Product (Y/N): N
• PMA/510(K) Number: K883723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: FBF-5.2-120
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 88 YR
• Patient Weight: 72