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

Model Number	G30964
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = other healthcare professional.Pma/510(k) number = k130293.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during preparation for an endovascular transluminal angioplasty of the superficial femoral artery (sfa), an advance 18 lp low profile balloon catheter would not maintain negative pressure.The user reportedly flushed the device and then attached an unknown inflation device to the balloon port.While pulling negative pressure, air was pulled into the inflation device and the balloon would not maintain negative pressure.The complaint device did not make contact with the patient.A new balloon worked as intended with the same inflation device.There has been no report that the patient required any additional procedures or experienced any adverse effects due to this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation/evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device were conducted during the investigation.The visual inspection of the returned device revealed no biomatter present on the product.The balloon was wrapped and appeared to have never been inflated, consistent with reported details that the device did not make patient contact.During the functional test, negative pressure was pulled with a syringe and inflation device.A vacuum was created and negative pressure maintained.The balloon was then inflated to the rated burst pressure with water and air.At no point during these tests was there an indication that the device had leaked.Rather, pressure was maintained throughout these tests.No damage or nonconformances were discovered on the return device.The device complaint was not supported based on visual and functional inspection.Additionally, a document-based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that no cause could be established for the stated device failure.While the complaint will be considered confirmed based on customer testimony, no evidence from the investigation supported deficiencies in the balloon catheter or the inflation device used.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8497301
• Report Number: 1820334-2019-00872
• Device Sequence Number: 1634024
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)210809(10)9080525
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Expiration Date: 08/09/2021
• Device Model Number: G30964
• Device Catalogue Number: PTA4-18-150-6-20
• Device Lot Number: 9080525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1