MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G50326
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional.Pma/510(k) number = k170193.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, prior to patient contact during an unknown procedure, an advance 14 lp low profile balloon catheter separated.The physician reported that the wire would not advance through the device and it felt as though something was stuck.The device reportedly separated "fully down the middle".Another device was used to complete the procedure.The patient reportedly had (b)(6).There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.

• Brand Name: ADVANCE 14 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: 9009899
• Report Number: 1820334-2019-02281
• Device Sequence Number: 11318428
• Product Code: LIT
• UDI-Device Identifier: 10827002503264
• UDI-Public: (01)10827002503264(17)220708(10)9863097
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: G50326
• Device Catalogue Number: PTAX4-14-170-2.5-20
• Device Lot Number: 9863097
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/12/2019
• Patient Sequence Number: 1