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

Catalog Number	CAT5
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system cat5 aspiration catheter (cat5) was fractured approximately 107.0 cm from the hub and ovalized in multiple locations along its distal 7.0 cm.There was no visible stretching of the cat5.When the fractured segments of the cat5 were pressed together, the effective length of the cat5 was measured to be within specification.There was no visible damage to the s indigo system separator 5 (sep5).Conclusion: evaluation of the returned devices revealed the cat5 was fractured and ovalized.The observed fractured may have occurred due to forceful manipulation of the cat5 during withdrawal from the patient.The distal ovalization may have occurred due to forceful handling during positioning within patient anatomy.There was no visible damage to the sep5.Penumbra separators and catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the popliteal and profunda femoris arteries using an indigo system cat5 aspiration catheter (cat5) and an indigo system separator 5 (sep5).During the procedure, the cat5 was removed to be flushed with the sep5 inside; however upon removal the physician noticed that the cat5 appeared to be stretched.The procedure was therefore completed using a new cat5 and new sep5.There was no report of an adverse effect to the patient.

• 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: 6894658
• Report Number: 3005168196-2017-01668
• Device Sequence Number: 13657914
• Product Code: DXE
• UDI-Device Identifier: 00814548016092
• UDI-Public: 00814548016092
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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
• Report Date (Section B): 09/05/2017

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 Catalogue Number: CAT5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR