MAUDE Adverse Event Report: SPECTRANETICS ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); ANGIOSCULPT RX PTCA

Model Number 2200-3015

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Apnea (1720); Pneumonia (2011); Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

The patient's dob or age at time of event, and weight are unknown.This information was not available from the facility.During withdrawal, the angiosculpt device separated in two pieces.Additional intervention was performed for removal with no success, thus the distal portion of the device was retained in the patient.The angiogram was received on 03/13/2020.Review of the angiogram revealed an implantable cardioverter-defibrillator (icd) in the heart (possibly a biventricular icd).The coronary angiogram presented a moderately calcified lad with a severe mid lesion, non-dominant left circumflex (lcx), and diffuse calcific disease of the dominant right coronary artery (rca).There was no ventriculography (lv gram) done.The mid lad lesion was predilated with a workhorse balloon, which showed a significant waist in the balloon during inflation, with eventual rupture of the balloon.After the predilatation, there was a non-flow limited dissection in the proximal part of the lesion, which did not inhibit passage of the angiosculpt balloon.It appears that the angiosculpt was inflated several times within the original lesion.Finally it appears that the angiosculpt was stuck in the proximal lad (proximal to the lesion).The last image had an unknown radio-opaque density in the guiding catheter (possibly a snare).Patient information regarding relevant tests/laboratory data is unknown.This information was not available from the facility.The angiosculpt device was returned taped to an unused angiosculpt device.The complaint device was returned without the entire distal assembly (distal tip, distal bond, balloon, scoring element, marker bands, intermediate bond, inner member, transition tubing, rx port (support tubing), support wire, proximal bond, distal shaft, and part of the intermediate shaft).The distal assembly portion of the device that was not returned is approximately 29 cm (11 inches).The returned portion includes a part of intermediate shaft, hypotube, core wire, strain relief, and luer.The hypotube was bent likely due to packaging for device return.The device separated approximately 108 cm from the breaking point (core wire) to the distal end of the strain relief.The overall catheter working length spec is 137 cm +/- 3 cm.During withdrawal, it is probable that the degree of force applied by the user may have caused or contributed to the device separation.Per the ifu, retained device component is listed as a possible adverse effect of the procedure.

Event Description

The patient was admitted with sleep apnea, pneumonia, made enzymes, and diagnosed with severe mid lad disease.The physician predilated the lesion with an apex balloon.To make it "look nicer," an angiosculpt device was advanced with no problem maneuvering the balloon down to the mid lad.The balloon was inflated multiple times below rbp (18 atm), with no issues.During withdrawal, the balloon got stuck in the proximal lad and not in the original lesion.No stent was present in the proximal lad with not much calcium observed.The physician moved the guiding catheter up to the balloon, tugged it 2-3 times with slight resistance, along with several inflation, but the device separated in 2 pieces and retained in the patient.The patient went into surgery and got a bypass to the lad.Due to the sleep apnea and pneumonia, the patient got tracheal post-op.Upon removal of the proximal shaft, the physician compared it to an unused angiosculpt device to measure the length of the retained portion.The physician believed the device separated at the distal transition point, and approximately 6-7 inches was retained in the body.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: ANGIOSCULPT RX PTCA
• 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 ; 510933-798
• MDR Report Key: 9894900
• MDR Text Key: 185505090
• Report Number: 3005462046-2020-00005
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 00813132021214
• UDI-Public: 00813132021214
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G19110022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention