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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number M00558670
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was unpacked on an unknown date.According to the complainant, the inner package had a hole in it.It was noted that the outer package did not have any damage.There was no patient or procedure involved.
 
Manufacturer Narrative
Date of event: date of event was approximated to 10/01/2019 as no event date was reported.Problem code 2385 captures the reportable event of inner packaging had a hole.Investigation result: a visual examination of the complaint device revealed that there is a hole in the middle of the pouch located at the right side near the information label in front of the pouch.It was also noted the package bonds around the pouch were continuous, intact and perfectly sealed.This failure is likely due to inappropriate transport or storage of the device.Therefore, the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
 
Event Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was unpacked on an unknown date.According to the complainant, the inner package had a hole in it.It was noted that the outer package did not have any damage.There was no patient or procedure involved.
 
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Brand Name
CRE PRO
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9272984
MDR Text Key182378574
Report Number3005099803-2019-05232
Device Sequence Number1
Product Code FGE
UDI-Device Identifier08714729797555
UDI-Public08714729797555
Combination Product (y/n)N
PMA/PMN Number
K112994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/21/2022
Device Model NumberM00558670
Device Catalogue Number5867
Device Lot Number0024149761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2019
Date Manufacturer Received11/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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