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

Model Number H749389420

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

Same case as mdr id# 2134265-2014-07903 and 2134265-2014-07904.It was reported that automatic pullback failure occurred.A 240v ilab ultrasound imaging system was used in conjunction with an atlantis¿ sr pro imaging catheter to visualize the unspecified lesion.During pullback, the imaging catheter failed to perform automatic pullback.Set up was checked to ensure no plastic was caught in the sled's wheel but everything was clear.The procedure was completed using manual pullback.No patient complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the complaint device was returned for analysis.The device appears to be in good condition.The telescope assembly was able to properly pull back, advance, and retract.By using a test pullback sled assembly, the catheter was able to properly pull back manually and automatically.No 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 root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

Same case as mdr id# 2134265-2014-07903 and 2134265-2014-07904.It was reported that automatic pullback failure occurred.A 240v ilab ultrasound imaging system was used in conjunction with an atlantis sr pro imaging catheter to visualize the unspecified lesion.During pullback, the imaging catheter failed to perform automatic pullback.Set up was checked to ensure no plastic was caught in the sled's wheel but everything was clear.The procedure was completed using manual pullback.No patient complications were reported.

• Brand Name: ATLANTIS? SR PRO
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4330109
• MDR Text Key: 5249099
• Report Number: 2134265-2014-07831
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K063312
• 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
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2015
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Device Lot Number: 17258246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2014
• 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