MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H74916599210

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

It was reported that a clot in the catheter was observed.The target lesion was located at the left main to left anterior descending (lad) artery.A 6f fl 3.5 impulse guide catheter was selected for use.The scrub nurse prepped the catheter with heparinized saline flush and inserted it via a medtronic exchange guide wire.However, the pressure waveform was absent so the catheter was removed and was flushed again with different heparin and from there a clot was observed to be in the catheter.Following this, another non - bsc catheter was used and patient recovered successfully.No patient complications were reported and the patient is stable.

• Brand Name: IMPULSE GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7453768
• MDR Text Key: 106267218
• Report Number: 2134265-2018-03184
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K000956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2018

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 Model Number: H74916599210
• Device Catalogue Number: 16599-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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