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

Catalog Number B1070-080

Device Problems Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was to treat a heavily calcified lesion in distal superficial femoral artery.Resistance was met with the calcification during advancement of the 7.0x80mm armada 35 balloon catheter to the target lesion.The balloon was inflated 3 times at 15 atmospheres, and during the 3rd inflation the balloon ruptured.Resistance was felt during removal of the armada and the ruptured balloon could not be pulled into the introducer sheath.The sheath was coming out of the groin and the patients' groin started to bleed/leak.The patient was sent to surgery with the sheath, shaft, and balloon all still in.The shaft was cut during surgery and the separated portion was successfully removed.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspections were performed on the returned device.The reported resistance met during advancement and removal could not be replicated in a testing environment as it was based on operational circumstances.The reported balloon rupture was confirmed.The instructions for use states: inflation in excess of the rated burst pressure (rbp) may cause the balloon to rupture.It is likely that inflating the balloon above the rbp contributed to the balloon rupture.The reported patient effects of hemorrhage, as listed in the armada 35, instructions for use is a known adverse event.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties, patient effects and treatment appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 35 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 6968807
• MDR Text Key: 89958600
• Report Number: 2024168-2017-08384
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K111899
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: B1070-080
• Device Lot Number: 70316G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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
• Treatment: INTRODUCER SHEATH: 6FR
• Patient Outcome(s): Required Intervention