MAUDE Adverse Event Report: COOK INC ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G26641
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name & product code = dqy catheter, percutaneous; lit catheter, angioplasty, peripheral, transluminal.(b)(6).Occupation = distributor device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 initially reported, during a below-the-knee angioplasty for ischemia and acute arterial occlusion, an advance micro 14 ultra low-profile pta balloon catheter would not advance.The device was prepared as usual and introduced over an unknown 0.014 inch guidewire, through an unspecified raabe sheath, to the desired artery.When the user attempted to advance the device distally, the device stopped advancing.The customer reportedly removed and inspected the device and "saw the inner lumen was moved from the original position".The device would not flush and the balloon would not inflate.Upon return and initial inspection of the device, the catheter tubing was observed to be cut/separated.Clarification was requested regarding if the device had been cut by the user or if the device separated during the procedure.Information obtained (b)(6) 2020 from the customer reported that the device was not intentionally cut by the user, but separated during the procedure.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
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: c summary of event: as initially reported, during a below-the-knee angioplasty for ischemia and acute arterial occlusion, an advance micro 14 ultra low-profile pta balloon catheter would not advance.The device was prepared as usual and introduced over an unknown 0.014 inch guidewire, through an unspecified raabe sheath, to the desired artery.When the user attempted to advance the device distally, the device stopped advancing.The customer reportedly removed and inspected the device and "saw the inner lumen was moved from the original position".The device would not flush and the balloon would not inflate.Upon return and initial inspection of the device, the catheter tubing was observed to be cut/separated.Clarification was requested regarding if the device had been cut by the user or if the device separated during the procedure.Information obtained 25mar2020 from the customer reported that the device was not intentionally cut by the user, but separated during the procedure.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.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the complaint device was conducted during the investigation.Physical examination of the returned device showed that the catheter tubing was separated approximately 2.3cm from the hub.The strain relief was not attached to the catheter nor returned with the complaint device.There was trace biomatter on the complaint device.There were various kinks in the catheter shaft.The kinks were located at approximately 72.5cm, 95.2cm, 97.5cm, 137.2cm, 141.5cm, and, 148.2cm from the distal end.There was no damage to balloon, however based on the condition of the balloon, the balloon has previously been attempted to be inflated.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file, device history record, complaint history, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu states: ¿in heavily scarred access sites, use of an introducer sheath is recommended.¿; ¿manipulate the catheter using fluoroscope control.¿; ¿under fluoroscopy, advance the balloon to the lesion site.Carefully position the balloon across the lesion using both the distal and proximal radiopaque balloon markers.Note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿; ¿if balloon pressure is lost and / or balloon rupture occurs, deflate balloon and remove balloon and sheath as unit.¿ based on the information provided and the results of the investigation, cook has found that a definitive conclusion could not be determined.The risk analysis for this failure mode was reviewed and no action was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9957087
• Report Number: 1820334-2020-00806
• Device Sequence Number: 2808114
• Product Code: LIT
• UDI-Device Identifier: 10827002266411
• UDI-Public: (01)10827002266411(17)201128(10)8399905
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K122940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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: 11/28/2020
• Device Model Number: G26641
• Device Catalogue Number: PTA3-14-150-2-12
• Device Lot Number: 8399905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68