MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; QEW

Model Number	CAT8XTORQ115
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the subclavian and brachial artery using an indigo system aspiration catheter 8 (cat8) and non-penumbra sheath.During the procedure, the physician made one pass in the target location using the cat8.Subsequently, when the physician removed the cat8 for flushing, the physician found the cat8 was damaged at the distal end.Therefore, the cat8 was not used for the remainder of the procedure.The procedure was completed using a new cat8 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the initial mfr report indicated that the device was not available for return due to the hospital discarded the device; however, the indigo system aspiration catheter 8 was returned on 17-mar-2021.Evaluation of the returned cat8 revealed that the catheter was stretched.If the cat8 is forcefully retracted against resistance, damage such as stretching may occur.Further evaluation of the returned cat8 revealed ovalization on the proximal shaft.This damage was incidental to the reported complaint and likely occurred during packaging for return.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11043093
• Report Number: 3005168196-2020-02318
• Device Sequence Number: 1087761
• Product Code: QEW
• UDI-Device Identifier: 00814548016290
• UDI-Public: 00814548016290
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020
• Report Date (Section F): 01/01/2005

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: 02/13/2022
• Device Model Number: CAT8XTORQ115
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: F88551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 04/17/2021
• Initial Report FDA Received Date: 12/20/2020
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005