MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT RX PTCA; CATHETER, PTCA, CUTTING/SCORING

Model Number 2200-2510

Device Problem Material Rupture (1546)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's weight, ethnicity, and race are unknown.This information was not available from the facility.The angiosculpt device was returned for evaluation; however, the returned product investigation has not begun, thus a supplemental report will be filed upon completion.

Event Description

The angiosculpt device was used to treat a severely calcified proximal rca.During inflation, the balloon ruptured at 14 atm despite the burst rate of 20 atm per the ifu.The procedure was completed with a non-angiosculpt device.No patient injury reported.This product problem is being submitted conservatively because the balloon ruptured below rbp.

Manufacturer Narrative

Block h2/h6: visual inspection found a lacerated distal shaft opposite side of the rx port.During functional testing, using an indeflator filled with green color dye water, the device was pressurized and at less than 2 atm, a distal shaft leak was observed on the opposite side of the rx port.Based on the lab analysis, the reported complaint of a balloon rupture could not be replicated; however, a shaft leak was noted.Per the manufacturer's work instruction, a shaft leak is not considered a reportable event.Supplemental report #1 submitted on 12/7/2021 was corrected to no longer reportable.

Manufacturer Narrative

Block b5: this event is no longer reportable based on the observations from the returned product analysis.No balloon rupture was observed as described in the complaint details.

Event Description

Initial mdr reported a balloon rupture below rbp.However, based on the observations from the returned product analysis, no balloon rupture was observed as described in the complaint details.Therefore, this event is no longer reportable.

• Brand Name: ANGIOSCULPT RX PTCA
• Type of Device: CATHETER, PTCA, CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer (Section G): SPECTRANETICS; 5055 brandin court; fremont CA 94538
• Manufacturer Contact: ana tan ; 5055 brandin court; fremont, CA 94538
• MDR Report Key: 12862818
• MDR Text Key: 281163755
• Report Number: 3005462046-2021-00070
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021177
• UDI-Public: 00813132021177
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2200-2510
• Device Catalogue Number: 2200-2510
• Device Lot Number: G21060033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• 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: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Age: 73 YR
• Patient Sex: Male