MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? SR PRO²; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749390140

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported that a hole was found on the catheter.During a percutaneous coronary intervention, the 90% stenosed target lesion was located in a moderately calcified and moderately tortuous middle left anterior descending coronary artery.An atlantis sr pro² imaging catheter was used in conjunction with a motor drive unit to view the lesion.During preparation, a hole was noticed on the connecting plastic portion of the imaging catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Manufacturer Narrative

Device returned to mfr: the device was returned for evaluation.Examination of the returned device revealed that the hub flaps appeared normal and a good click sound was heard during insertion into the mdu system.Fluid was leaking at the male/female luer connection was connected when the catheter was flushed.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that a hole was found on the catheter.During a percutaneous coronary intervention, the 90% stenosed target lesion was located in a moderately calcified and moderately tortuous middle left anterior descending coronary artery.An atlantis¿ sr pro² imaging catheter was used in conjunction with a motor drive unit to view the lesion.During preparation, a hole was noticed on the connecting plastic portion of the imaging catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.

• Brand Name: ATLANTIS? SR PRO²
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3726104
• MDR Text Key: 4328556
• Report Number: 2134265-2014-01804
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2014

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: 09/12/2014
• Device Model Number: H749390140
• Device Catalogue Number: 39014
• Device Lot Number: 16376478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2013
• 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