MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1070-020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to position the guide wire/sheath and difficulty removing the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a non-tortuous and mildly calcified lesion located in the renal artery.A 7.0 x 20 mm armada 35 balloon catheter could not advance over an unspecified guide wire as resistance was felt through a 6fr introducer sheath.Resistance was met during the removal of the balloon catheter from the guide wire.The guide wire remained in the patient and a 4fr balloon catheter was successfully advanced over the guide wire instead to complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7473048
• Report Number: 2024168-2018-03154
• Device Sequence Number: 13492144
• Product Code: LIT
• UDI-Device Identifier: 08717648154775
• UDI-Public: 08717648154775
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2018

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: 06/30/2021
• Device Catalogue Number: B1070-020
• Device Lot Number: 80102G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/30/2018
• 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
• Patient Weight: 60