MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #: k130293; the number was not able to populate in the field.The device is anticipated to be returned, but has not yet been received by the manufacturer.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information and/or completion of the investigation.

Event Description

It was reported that during the superficial femoral artery (sfa) intervention the balloon ruptured in the lesion.The medical team's initial attempts to remove the balloon where unsuccessful because only part of the balloon would re-enter the sheath.Continued attempts at removal caused the balloon to separate.Half of it came out on the guide wire, while another piece came out later on the other end of the wire.The physician had to reaccess the site, but was able to successfully retrieve the remaining piece with a snare.There was no reported adverse event or injury to the patient as a result of the event.

Manufacturer Narrative

Investigation - evaluation: a review of complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and visual inspection of the returned device were completed during this investigation.One advance 18 lp low profile balloon catheter was returned for evaluation.It was noted that the pta4 device was returned with a non-cook device (snare) and the distal portion of the balloon was attached.The balloon was separated into two sections.Both the proximal and distal bonds were smooth and free of damage.The surface of the catheter shaft was smooth and no damage was present.The inner tubing with marker band material (inside the balloon) was separated from the proximal and distal bonds and there were no marker bands present.It measured 23.9cm in length.It is noted that 1.0cm of one end was twisted.A document-based investigation was performed.Review of the device history record of the finished product shows one nonconforming event that could contribute to this failure mode.There were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.The balloon is 100% inspected and verified.Further information revealed, the inflation pressure used was 8atm.The contrast used and the mix of contrast to saline was visipaque - 30% contrast and 70% saline.There was a lesion in the distal sfa and proximal pop.No angulation was used.The vessel was highly calcified.The balloon burst circumferentially.There was a wire guide in place during the attempted removal.The balloon was allowed to return to ambient pressure because there was a rupture.There was no clockwise rotation of the balloon during catheter withdrawal.Per the ifu , "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site." it is plausible to suggest the attempt to "re-enter the sheath" and failure to withdraw the catheter in a counterclockwise rotation may have led to balloon separation.The customer stated the "vessel was highly calcified." per the ifu, "the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage." based upon the information provided, examination of the returned product and the characteristics displayed, it is plausible to suggest that this incident was user human anatomy related or failure to follow instruction or label related.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6733714
• MDR Text Key: 80707309
• Report Number: 1820334-2017-01687
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309569
• UDI-Public: (01)10827002309569(17)200424(10)7853466
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA4-18-150-5-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 DA