MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1014256-120

Device Problems Difficult to Insert (1316); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a mildly calcified 70% stenosed, de novo lesion in the superficial femoral artery.The armada 18 balloon dilatation catheter (bdc) was inserted through a 4f introducer sheath and percutaneous transluminal angioplasty was performed in the left leg.The armada 18 balloon was removed; however the bdc could not be reinserted through the introducer sheath.To treat the right leg, another antegrade puncture was performed and a 6f introducer sheath was used.The armada bdc was reinserted through the 6f introducer sheath however during the first inflation, the balloon ruptured at nominal pressure (8 atmospheres).The armada bdc was removed and the procedure was completed with an unspecified bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation and the reported difficulty to advance into the introducer sheath was not confirmed due to the condition of the returned balloon.The balloon rupture was confirmed.Based on visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the difficulty could not be determined.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents reported from this lot.It should be noted that the armada 18 instruction for use states: refer to the package label for information about catheter length, guide wire compatibility, nominal and rated burst pressure, and sheath compatibility.Information about catheter length, guide wire compatibility, nominal and rated burst pressure, and sheath compatibility.The recommended sheath on the label for this device is a 5f sheath.It is likely that use of the undersized introducer sheath caused the difficulty.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5390745
• MDR Text Key: 36948933
• Report Number: 2024168-2016-00435
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 1014256-120
• Device Lot Number: 5051241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1