MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Catalog Number	CAT3
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 cat3 aspiration catheter (cat3).During the procedure, the physician successfully removed the clot using the cat3.After removal of the clot, the physician noticed that the cat3 broke in half while in the patient's leg.The physician required a snare device to remove both broken halves of the cat3 from the patient.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the penumbra indigo system aspiration catheter (cat3) was fractured approximately 48.0 cm from the distal tip.Conclusion: evaluation of the returned device confirmed that the cat3 was fractured.This type of damage typically occurs due to improper handling during use.Even though the physician mentioned that he did not experience resistance during withdrawal of the catheter, if the device was retracted at an angle with excessive force, damage such as this may occur.In addition, the observed fracture did not occur at a junction location.All lots are tested for tensile strength and all tested units from the lot related to this cat3 met the specification.The proximal end of the fractured cat3 was not returned for evaluation and the scope of the investigations was, therefore, limited.The cat3s are 100% visually inspected for damage 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 CAT3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5355418
• Report Number: 3005168196-2016-00018
• Device Sequence Number: 16171748
• Product Code: DXE
• UDI-Device Identifier: 00814548013299
• UDI-Public: 00814548013299
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Report Date (Section B): 12/09/2015

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/18/2018
• Device Catalogue Number: CAT3
• Device Lot Number: F64014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2016
• 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: Required Intervention