MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-2-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility reported that during a procedure the device was advanced using an ipsilateral approach from the right femoral artery to the posterior tibial artery of the occluded ata.The balloon ruptured during the second attempt of dilation.It was reported that it was unknown if the rupture was longitudinally or circumferentially.The reporter stated it was believed by the physician that this occurrence was probably due to the calcified lesion.Another cook ptax4 balloon of a different size was used to complete the procedure since another attempt of dilation was required to complete the procedure.There were no reported adverse effects to the patient.It was reported that the device will not be returned.
Additional Manufacturer Narrative
Corrected information: report source.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and inspection of unused product was conducted during the investigation.The complaint device was not returned; however, a representative advance 14lp low profile balloon catheter from the same lot #7381568 was returned for evaluation.The balloon was checked for surface defects and no non-conformities were noted.The balloon inflated to 17atm without bursting.The rated burst pressure on this device is 16atm.The device measured within specifications.The catheter was inspected for defects and damage and no non-conformities were noted.The balloon length and diameter measured within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events.A review of the two sub-assembly device history records showed 15 non-conformances; however, all non-conforming product was scrapped or re-worked as appropriate, prior to completion of the final lot.There were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation; the root cause has been determined to be related to patient anatomy, however, user technique and/or the use of other devices which are incompatible cannot be ruled out as contributing factors to the reported event.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 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7138185
• Report Number: 1820334-2017-04306
• Device Sequence Number: 16411426
• Product Code: DQY
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)191024(10)7381568
• Combination Product (Y/N): N
• 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): 01/11/2018

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 Catalogue Number: PTAX4-14-170-2-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1