MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24628

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Integrity Problem (2978)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon deflation failure occurred.The 50% stenosed target lesion was an area of in-stent restenosis (isr) located in the non-calcified vessel in the forearm.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was inflated twice at 10 atmospheres for 60 seconds.Upon deflation, it was depressurized to 2 atmospheres for few seconds.However, it was noted that the balloon waited for 30 seconds at 2 atmospheres before it was depressurized to 0 atmospheres.Angiography was performed and during removal, resistance was noted with the sheath.Upon removal, the sheath got separated.Both guidewire and sheath were removed together.No patient complications were reported.

Manufacturer Narrative

B5 updated and corrected e1 - initial reporter city: (b)(4).

Event Description

It was reported that balloon deflation failure occurred.The 50% stenosed target lesion was an area of in-stent restenosis (isr) located in the non-calcified vessel in the forearm.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was inflated twice at 10 atmospheres for 60 seconds.Upon deflation, it was depressurized to 2 atmospheres for few seconds.However, it was noted that the balloon waited for 30 seconds at 2 atmospheres before it was depressurized to 0 atmospheres.Angiography was performed and during removal, resistance was noted with the sheath.Upon removal, the sheath got separated.Both guidewire and sheath were removed together.No patient complications were reported.It was further reported that the target vessel did not contain a previously implanted stent as previously reported.The device was used in plain old balloon angioplasty (poba) which was repeatedly performed.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device found that the balloon had been inflated.A visual and microscopic examination identified no issues with the catheter tip, balloon, markerbands or blades of the device.All blades were fully bonded to the balloon material.No damage or kinks were noted to the shaft of the device.The investigator successfully advanced the device through a boston scientific 6fr introducer sheath and removed it without issue.It was noted that the customers guidewire was damaged when it was returned.The balloon was inflated and deflated without issue.No issues were noted with the returned device that could potentially have contributed to the complaint incident.No issues or damage was noted with the balloon material, balloon profile or blades.All blades were present and fully bonded to the balloon material.

Event Description

It was reported that balloon deflation failure occurred.The 50% stenosed target lesion was an area of in-stent restenosis (isr) located in the non-calcified vessel in the forearm.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the device was inflated twice at 10 atmospheres for 60 seconds.Upon deflation, it was depressurized to 2 atmospheres for few seconds.However, it was noted that the balloon waited for 30 seconds at 2 atmospheres before it was depressurized to 0 atmospheres.Angiography was performed and during removal, resistance was noted with the sheath.Upon removal, the sheath got separated.Both guidewire and sheath were removed together.No patient complications were reported.It was further reported that the target vessel did not contain a previously implanted stent as previously reported.The device was used in plain old balloon angioplasty (poba) which was repeatedly performed.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12779231
• MDR Text Key: 280531993
• Report Number: 2134265-2021-13855
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0027578011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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
• Treatment: GUIDE CATHETER: KYOUSHA; GUIDE CATHETER: KYOUSHA; GUIDE CATHETER: KYOUSHA; INTRODUCER SHEATH: MOSQUITO 6FR; INTRODUCER SHEATH: MOSQUITO 6FR; INTRODUCER SHEATH: MOSQUITO 6FR
• Patient Sex: Male