MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT5 ASPIRATION CATHETER; DXE

Catalog Number	CAT5
Medical Device Problem Codes	Break (1069); Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system cat5 aspiration catheter (cat5) was kinked approximately 37.0 and fractured approximately 81.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was fractured and kinked.This type of damage typically occurs due to forceful withdrawal of the cat5 from the packaging hoop at extreme angles.Cat5 devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a thrombectomy procedure, the hospital staff found that the indigo system cat5 aspiration catheter (cat5) was kinked upon removal from the packaging.The damaged cat5 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new cat5.
Additional Manufacturer Narrative
Describe event or problem on the initial mfr report indicated that the indigo system cat5 aspiration catheter (cat5) was kinked upon removal from the packaging.This sentence should have stated that the cat5 was also found broken upon removal from the packaging.Based on the information above, an additional device code should have been reported on the initial mfr report and is being added to this follow-up #1 mfr report.

• Brand Name: INDIGO SYSTEM CAT5 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5674244
• Report Number: 3005168196-2016-00713
• Device Sequence Number: 18835916
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K121917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2018
• Device Catalogue Number: CAT5
• Device Lot Number: F66012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1