MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA3-14-90-2.5-10

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2024

Event Type  malfunction  

Event Description

As reported, during a below-the-knee angioplasty via antegrade access, an advance micro 14 ultra low-profile pta balloon catheter ruptured.Another manufacturer's 6-french sheath was used during the procedure.The complaint device was reportedly difficult to track to the lesion due to calcification, which was noted during wire advancement and imaging.The balloon catheter could not track more than seven centimeters from the start of the proximal segment of the vessel.The balloon was inflated one time within a stenosed lesion in the proximal section of a crural vessel, using another manufacturer's inflation device, to approximately six-to-eight atmospheres; however, the balloon ruptured longitudinally.The entire length of the vessel was significantly calcified and had poor run off, with "thready" and "patchy" flow along the length of the vessel.Blood was not noted in the inflation device, and the balloon was not inflated within a stent.The device was retrieved through the sheath, using an unspecified snare.Treatment of other vessels was completed with another balloon; however, the vessel being treated at the time of this event was left untreated, due to calcification and other issues.A section of the device did not remain inside the patient¿s body.Although the length of the procedure was extended due to retrieval of the device, no additional procedures or treatments were needed, and the hospital stay was not extended.The patient is reportedly "ok" and did not experience any adverse effects due to this event.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D2: common name & product code = dqy: dqy catheter, percutaneous; lit: lit catheter, angioplasty, peripheral, transluminal e1: customer name and address = phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18988249
• MDR Text Key: 338729776
• Report Number: 1820334-2024-00430
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002264073
• UDI-Public: (01)10827002264073(17)260718(10)15564154
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA3-14-90-2.5-10
• Device Lot Number: 15564154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6FR CORDIS BRITETIP SHEATH; BOSTON ENCORE INFLATION DEVICE