MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number 1973-03

Device Problem Material Rupture (1546)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon ruptured occurred.A 5.0mm x 200mm x 150cm ranger balloon was selected for the treatment of peripheral arterial disease in the left superficial femoral artery.Calcification could not be confirmed on fluoroscopy.There was approximately 3cm chronic total occlusion.A sterling (5-150) was used for pre-inflation.The sterling balloon was inflated once to 10-14 atmospheres (atms).During this inflation, the balloon ruptured.The device was removed without problem using the normal method.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).Device eval by mfr: the returned product consisted of a ranger drug coated balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in 4.8cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that a balloon ruptured occurred.A 5.0mm x 200mm x 150cm ranger balloon was selected for the treatment of peripheral arterial disease in the left superficial femoral artery.Calcification could not be confirmed on fluoroscopy.There was approximately 3cm chronic total occlusion.A sterling (5-150) was used for pre-inflation.The sterling balloon was inflated once to 10-14 atmospheres (atms).During this inflation, the balloon ruptured.The device was removed without problem using the normal method.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13029062
• MDR Text Key: 282498935
• Report Number: 2134265-2021-15786
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976042
• UDI-Public: 08714729976042
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P190019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 05328H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2021
• 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