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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).K130293.The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A advance 18 lp low profile balloon catheter was used in a balloon angioplasty.It was reported that, the balloon ruptured before reaching nominal pressure.The balloon was removed and replaced and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
An advance 18 lp low profile balloon catheter was used in a balloon angioplasty.It was reported that, the balloon was being inflated at the site where the stent was placed and restenosis was present.The balloon ruptured before reaching nominal pressure.The balloon was removed and replaced and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 18 lp low profile balloon catheter was returned for investigation.Bio-material appears to be present inside the catheter shaft.Balloon ruptured longitudinally from the proximal end of balloon.The rupture is 3.0cm in length.The returned device met dimensional requirements.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 that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned device, and the results of our investigation, a definitive root cause could not be determined.Measures have been initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6843193
• Report Number: 1820334-2017-02741
• Device Sequence Number: 684299
• Product Code: LIT
• UDI-Device Identifier: 10827002343228
• UDI-Public: (01)10827002343228(17)200629(10)8028592
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: PTA4-18-150-3-10
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 09/11/2017; 11/16/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/11/2017; 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1