MAUDE Adverse Event Report: CRYOLIFE, INC. SOLOGRIP III HANDPIECE; SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION

Model Number HP-SG3

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

A sample evaluation was performed for the returned handpiece, lot number ta-04108, serial (b)(4).The thumb slide was stuck at the most forward position (maximum optical fiber travel), with excessive force, the thumb slide finally moved back accompanies by an audible click.Once the thumb slide was freely moving, it was noticed that the polypropylene sheath covering the optical fiber bundle was damaged (cracked and starting to peel away) at the end of the optical fiber.It is possible there was an excessive amount of adhesive in the handle that caused the thumb slide to adhere to the handle.The plastic parts that make up the handle are assembled using adhesive during manufacturing.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Per the initial report, "[complainant] called to let me know that [surgeon] had two (2) sologrip iii handpieces that where not functioning properly.He was not in the case, but texted me the number of [nurse] whom was scrubbed into [surgeon]'s case.This surgical team is very experienced with the cardiogenesis tmr laser procedure and products.I call [nurse] to discuss the case.She said they opened the first sologrip iii and she said that "the device did not look normal and the "cable was not connected to the "bubble" of the device." they immediately opened a second sologrip iii handpiece, but [surgeon] and [nurse] tried, but could not make the laser channel mechanism to retract.A third sologrip iii was opened and worked as it should and was used in the case with normal standards and results.".

Manufacturer Narrative

A visual examination of the returned handpiece was performed.The thumb slide was stuck at the most forward position (maximum optical fiber travel), with excessive force, the thumb slide finally moved back accompanies by an audible click.Once the thumb slide was freely moving, it was noticed that the polypropylene sheath covering the optical fiber bundle was damaged (cracked and starting to peel away) at the end of the optical fiber.A definitive root cause cannot be identified based on this evaluation; however, it is possible there was an excessive amount of adhesive in the handle that caused the thumb slide to adhere to the handle.The plastic parts that make up the handle are assembled using adhesive during manufacturing.The returned handpiece was sent to [contract manufacturer] for an additional evaluation.The unit was reviewed by the production lead.It appears the fiber was stuck somewhere that caused the sleeve to open.No excess of uv glue or locitite was present.The handpiece was taken apart for review and testing - no obstructions were found to hinder the movement at the tube support interface.The manufacturing records for the hp-sg3, ta-04108-34, were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.This event does not identify additional hazards or modify the probability and severity of existing hazards.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

Per the initial report, "[complainant] called to let me know that [surgeon] had two (2) sologrip iii handpieces that where not functioning properly.He was not in the case, but texted me the number of [nurse] whom was scrubbed into [surgeon]'s case.This surgical team is very experienced with the cardiogenesis tmr laser procedure and products.I call [nurse] to discuss the case.She said they opened the first sologrip iii and she said that "the device did not look normal and the "cable was not connected to the "bubble" of the device." they immediately opened a second sologrip iii handpiece, but [surgeon] and [nurse] tried, but could not make the laser channel mechanism to retract.A third sologrip iii was opened and worked as it should and was used in the case with normal standard s and results." this report is relegated to the second handpiece where the hospital staff could not make the "laser channel mechanism to retract.".

• Brand Name: SOLOGRIP III HANDPIECE
• Type of Device: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 7456571
• MDR Text Key: 107089898
• Report Number: 1063481-2018-00012
• Device Sequence Number: 1
• Product Code: MNO
• UDI-Device Identifier: 00877234000102
• UDI-Public: (01)00877234000102(17)190326(10)TA-04108(21)
• Combination Product (y/n): N
• PMA/PMN Number: P970029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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: Physician
• Device Model Number: HP-SG3
• Device Catalogue Number: HP-SG3
• Device Lot Number: TA-04108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Distributor Facility Aware Date: 03/26/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1