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

Catalog Number	CAT5
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system cat5 aspiration catheter (cat5).During the procedure, the cat5 became buckled while it was being advanced through another manufacturer's sheath for the second pass.The procedure was still successfully completed using the same cat5.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the indigo system cat 5 aspiration catheter (cat5) was kinked approximately 36.0 cm from the hub and ovalized approximately 120.0 cm from the hub.Conclusions: evaluation of the returned device revealed it was kinked.This type of damage typically occurs due to forceful advancement of the cat5 against resistance.Further evaluation revealed the cat5 was ovalized.This damage was likely incidental and may have occurred during removal of the cat5 from the patient.The non-penumbra sheath mentioned in the complaint was not returned for evaluation.Penumbra catheters are 100% visually evaluated during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 5539861
• Report Number: 3005168196-2016-00410
• Device Sequence Number: 942546
• Product Code: DXE
• UDI-Device Identifier: 00814548013305
• UDI-Public: 00814548013305
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 03/03/2016

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: Physician
• Device Expiration Date: 01/23/2018
• Device Catalogue Number: CAT5
• Device Lot Number: F62389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2016
• Supplement Report FDA Received Date: 05/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR