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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿ SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC

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BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPIO¿ SLIM; HOLDER, NEEDLE, GASTROENTEROLOGIC Back to Search Results
Model Number M0068318261
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6) (b)(4).The complainant indicated that the device is disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a capio¿ slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2017.According to the complainant, while suturing the sacrospinous ligament, the needle detached from the suture and was found inside the cage.The procedure was completed with another capio¿ slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
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Brand Name
CAPIO¿ SLIM
Type of Device
HOLDER, NEEDLE, GASTROENTEROLOGIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6590091
MDR Text Key75916841
Report Number3005099803-2017-01481
Device Sequence Number1
Product Code FHQ
UDI-Device Identifier08714729842224
UDI-Public(01)08714729842224(17)20190608(10)0019335461
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/05/2017
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 Date06/08/2019
Device Model NumberM0068318261
Device Catalogue Number831-826
Device Lot Number0019335461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/05/2017
Initial Date FDA Received05/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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